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NCT00513695 · ClinicalTrials.gov registry record · Phase 2
Sunitinib Malate, Paclitaxel, Doxorubicin Hydrochloride, and Cyclophosphamide Before Surgery in Treating Patients With Stage IIB-IIIC Breast Cancer
A Phase 2 study of Stage II Breast Cancer and Stage IIIA Breast Cancer, sponsored by University of Washington.
- Completed
- Registry status
- Phase 2
- Development phase
- 68
- Enrollment target
- 7
- Study locations
NCT00513695: Completed Phase 2 study of Stage II Breast Cancer and Stage IIIA Breast Cancer, sponsored by University of Washington.
NCT00513695 is a Phase 2 study of Stage II Breast Cancer and Stage IIIA Breast Cancer that has completed, run by University of Washington. The registered enrollment target is 68 participants, below the 317-participant average among 30 other Stage II Breast Cancer trials with a reported enrollment target (79% lower). The trial reports 7 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00513695, a Phase 2 study of Stage II Breast Cancer and Stage IIIA Breast Cancer, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 68 participants
- Enrollment target
- 7
- Study locations
Study Summary
This phase II trial studies how well giving sunitinib malate together with paclitaxel, doxorubicin hydrochloride, and cyclophosphamide before surgery works in treating patients with stage IIB-IIIC breast cancer. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel, doxorubicin hydrochloride, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sunitinib malate together with combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed
Primary Outcome
Defined as no evidence of microscopic invasive tumor present at primary tumor site in the surgical specimen and calculated with exact 90% binomial confidence interval.
Conditions Studied
Interventions
- DRUG cyclophosphamide
- DRUG paclitaxel
- BIOLOGICAL filgrastim
- DRUG doxorubicin hydrochloride
- DRUG sunitinib malate
Study Locations (7)
Washington
- Skagit Valley Hospital - Mount Vernon
- Olympic Medical Center - Port Angeles
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium - Seattle
Alaska
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
Arizona
- Arizona Cancer Center - Tucson
Idaho
- Saint Luke's Mountain States Tumor Institute - Boise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2007-06 |
| Est. Completion | 2017-10-16 |
| Phase | Phase 2 |
What the finished NCT00513695 record still lists
NCT00513695 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 317-participant average among 30 other Stage II Breast Cancer trials with a reported enrollment target (79% lower).
The record links to 6 conditions, with Stage II Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT00513695 lists 7 locations in 4 states (Washington, Alaska, Arizona).
Frequently Asked Questions
What is clinical trial NCT00513695 about?
NCT00513695 is a clinical study titled "Sunitinib Malate, Paclitaxel, Doxorubicin Hydrochloride, and Cyclophosphamide Before Surgery in Treating Patients With Stage IIB-IIIC Breast Cancer". This phase II trial studies how well giving sunitinib malate together with paclitaxel, doxorubicin hydrochloride, and cyclophosphamide before surgery works in treating patients with stage IIB-IIIC breast cancer. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes need...
What is the current status of trial NCT00513695?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2007-06. Estimated completion is 2017-10-16.
What conditions does trial NCT00513695 study?
This clinical trial studies the following conditions: Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Male Breast Cancer.
What interventions are being tested in trial NCT00513695?
The interventions under investigation include: cyclophosphamide (DRUG), paclitaxel (DRUG), filgrastim (BIOLOGICAL), doxorubicin hydrochloride (DRUG), sunitinib malate (DRUG).
Who is sponsoring clinical trial NCT00513695?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00513695 being conducted?
This trial has 7 study locations across Alaska, Arizona, Idaho, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage II Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00513695's enrollment target sits among peer trials
68 17th of 30 higher than 14 of 30 other Stage II Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage II Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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